Catheter having insertion control mechanism

ABSTRACT

The present invention is a catheter having a tube and including mechanisms that provide precision control over insertion and retraction of the catheter tube. The catheter is particularly adapted for introduction into the pulmonary system. The catheter includes an insertion depth control mechanism that acts as a stop and provides a tactile indication to the person inserting the catheter tube that a predetermined position has been reached. The catheter also includes an anti-bunching mechanism to prevent bunching of a protective sleeve disposed around the catheter tube, thereby reducing interference from the sleeve during insertion of the catheter tube.

PRIORITY CLAIM

[0001] This application is a continuation of and claims the benefit ofU.S. patent application Ser. No. 09/610,644, filed Jun. 12, 2000, whichis a continuation of U.S. patent application Ser. No. 09/038,465, filedMar. 11, 1998, which claims priority to provisional U.S. patentapplication Ser. No. 60/040,678, filed Mar. 11, 1997.

CROSS REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to the following commonly-ownedco-pending patent application: “SLEEVED CATHETER HAVING INSERTIONCONTROL MECHANISM”, Attorney Docket No. 0112460-189, filed Jan. 30,2004.

TECHNICAL FIELD

[0003] The present invention relates to medical catheters, and moreparticularly to catheters used to remove substances from, or introducesubstances into, the pulmonary system or gastrointestinal tract of apatient.

BACKGROUND OF THE INVENTION

[0004] In certain medical treatment situations, catheters must beprecisely introduced into a patient's pulmonary system orgastrointestinal tract for various functions. For example, a patient mayrequire involuntary aspiration of secretions from the patient's lungs.In this situation, a suction catheter can be introduced into thepatient's airway and lungs to remove the secretions via suction throughthe catheter. In addition, a patient may require introduction of varioussubstances into the body through such catheters. For example, a patientmay require the introduction of a lavage solution into the lungs toloosen secretions without interfering with ventilation.

[0005] Respiratory distress frequently occurs in infants and smallchildren, especially prematurely born infants. Premature infants mayrequire repeated pulmonary intervention. When an infant-or small childis unable to effectively breathe on their own, intubation andinvoluntary ventilation is provided via an endotracheal tube. In caringfor infant patients, it is necessary to periodically suction outsecretions that would otherwise accumulate in the infant's lungs. Thisrequires periodic involuntary removal of secretions from the lungs via asmall suction catheter tube without injury to the lungs. Suctioningand/or introduction of therapeutic substances may take placeintermittently during ventilation.

[0006] Suctioning is generally accomplished by introducing and advancingone end of a flexible suction catheter tube into the endotracheal tubeand applying suction to the other end of the catheter tube. To reducethe extent of airway occlusion, the catheter tube is typically withdrawnfrom the endotracheal tube when the catheter is not in use.

[0007] Before the catheter tube is advanced through the endotrachealtube, the catheter tube may be “exposed” within the catheter assembly.However, many catheters include a flexible sleeve that covers the spanof tubing between the fittings of a catheter to avoid the introductionof microbial pathogens during intubation. The sleeve encloses thecatheter tube and preserves the sterility of the tube in a closedsystem. The sleeve remains fixed to the fittings of the catheter. Thesleeve is flexible so that the catheter can be advanced by manipulatingthe catheter from the outside of the sleeve. Thus, the catheter may beintermittently introduced without breaking the sterile field created bythe sleeve around the catheter.

[0008] Precise control over the placement of the catheter tube is alsorequired to reduce the risk of injury during placement. The cathetermust be advanced far enough to effectively reach the lungs withoutdamaging tissue by overextension of the catheter. The use of a catheterhaving a protective sleeve further impacts control over the catheterduring placement. As the catheter is fully advanced, the sleeve maybunch, making precise control more difficult. Thus, there is a need fora catheter having a mechanism for controlling insertion depth whilepreventing bunching of the protective sleeve as the catheter isinserted.

SUMMARY OF THE INVENTION

[0009] The present invention is a catheter having a tube and includingmechanisms that provide precision control over insertion and retractionof the catheter tube. The catheter is particularly adapted forintroduction into the pulmonary system. The catheter includes aninsertion depth control mechanism that acts as a stop and provides atactile indication to the person inserting the catheter tube that apredetermined position has been reached. The catheter also includes ananti-bunching mechanism to prevent bunching of a protective sleevedisposed around the catheter tube, thereby reducing interference fromthe sleeve during insertion of the catheter tube.

[0010] In one embodiment, the insertion depth control mechanismcomprises an insertion control member that is adjustably positioned onthe catheter tube. The insertion control member includes a releasablecatch to permit adjustment of its position along the catheter tube. Whenplaced in a predetermined position that corresponds to a predeterminedinsertion depth, the insertion control member acts as a stop against aconnector or other form attached to the tube. When the insertion controlmember reaches the connector or form during insertion of the tube, itbumps against the connector or form and stops the advancement of thecatheter tube at a predetermined length. This resistance provides atactile response, or feel, to a person inserting the catheter, whichindicates that the catheter tube has been inserted to the predetermineddepth. The insertion control member can comprise a number of differentshapes.

[0011] In one embodiment, the anti-bunching mechanism comprises a sleevespreader including an outer surface concentrically disposed around thecatheter tube and adjacent a tube opening of a distal connector attachedto the catheter. The sleeve spreader deflects the sleeve away from thetube opening of the distal connector and prevents it from bunching atthe tube opening, thereby avoiding interference with advancement of thecatheter tube.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012]FIG. 1 is a perspective view of a catheter of the presentinvention including a connector for a ventilation apparatus.

[0013]FIG. 2A is a perspective view of a first embodiment of aninsertion control member of the present invention.

[0014]FIG. 2B is a cross-sectional view of the insertion control membershown in FIG. 2A taken transversely through the center of the insertioncontrol member.

[0015]FIG. 3 is a cross-sectional side view of a second embodiment of aninsertion control member of the present invention.

[0016]FIG. 4 is a cross-sectional view of a sleeve spreader of thecatheter shown in FIG. 1.

[0017]FIG. 5A is an elevational view of a second embodiment of a sleevespreader of the present invention.

[0018]FIG. 5B is a cross-sectional view of the sleeve spreader shown inFIG. 5A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] While the present invention will be described fully hereinafterwith reference to the accompanying drawings, in which a particularembodiment is shown, it is to be understood at the outset that personsskilled in the art may modify the invention herein described while stillachieving the desired result of this invention. Accordingly, thedescription which follows is to be understood as a broad informativedisclosure directed to persons skilled in the appropriate arts and notas limitations of the present invention.

[0020]FIG. 1 is an exploded view of a suction catheter 20 and associatedattachments for use in a typical ventilator circuit. The suctioncatheter 20 incorporates an insertion depth control mechanism and ananti-bunching mechanism as described herein. The suction catheter 20includes a catheter tube 21, a proximal end 22 having a proximalconnector assembly 24, and a distal end 26 having a distal spreaderconnector 28. The proximal connector assembly 24 includes a sleevecollar 30, a vacuum valve 32, and a terminal connector 34. The distalspreader connector 28 includes a sleeve collar 35 and a generallycone-shaped extension 36 that extends toward the proximal end 22 of thecatheter 20. The cone-shaped extension includes a tube aperture 37. Thecatheter tube 21 passes through the tube aperture 37. The distalspreader connector 28 has a fitting 38 that can be connected to anadapter device 39. To complete the ventilation circuit, the adapterdevice 39 is connected to a conventional ventilation adapter 40 thatincludes an endotracheal tube 42 having an end opening 44. Othercomponents may be used in connection with the suction catheter 20without departing from the present invention, such as those disclosed inU.S. Pat. No. 5,642,726, which is incorporated herein by reference.

[0021] The catheter tube 21 of the suction catheter 20 is surrounded bya flexible external sleeve 46 that spans from the proximal connectorassembly 24 to the distal spreader connector 28, as shown in FIG. 1. Theexternal sleeve 46 is attached to the proximal connector assembly 24within the sleeve collar 30 and the distal spreader connector 28 withinthe sleeve collar 35. The sleeve 46 may be banded to the sleeve collars30 and 35 or adhered thereto. The external sleeve 46 encloses thecatheter tube 21 to preserve its sterility during use in a closedsystem.

[0022] During intubation, the catheter tube 21 of the suction catheter20 is introduced into the endotracheal tube 42 through the distalspreader connector 28 and the adapter device 39 and advanced to apredetermined depth. The depth of insertion is controlled by aninsertion control member 50. During insertion of the catheter tube 21,the insertion control member 50 acts as a stop against the cone-shapedextension 36 of the distal spreader connector 28, thus stopping theadvancement of the catheter at a predetermined length. The insertioncontrol member 50 also provides a tactile feel to the operator when itbumps against the extension 36, thereby signaling to the operator thatthe proper depth has been reached.

[0023] In the embodiment depicted in FIG. 1, the insertion controlmember 50 has a generally barreled shape as shown in FIGS. 2A and 2B.The insertion control member 50 includes two flattened grip portions 52and a tube passage 54. As shown in FIG. 2B, the tube passage 54 has anelongated cross-section near the center of the insertion control member50. The catheter tube 21 passes through the tube passage 54 and theelongated configuration of the tube passage 54 grips the catheter tube21 to hold the insertion control member 50 at a predetermined positionalong the catheter tube 21. The catheter tube 21 may include indicia tohelp facilitate depth adjustment of the catheter tube 21 via theinsertion control member 50. The position of the insertion controlmember 50 can be adjusted by an operator pinching the insertion controlmember 50 at the flattened grip portions 52 to flex the elongatedcross-section of the of the tube passage 54 to form a relatively widercross-section. The wider cross-section allows the operator to slide theinsertion control member 50 to a new position on the catheter tube 21.When the insertion control member 50 is repositioned, the operatorreleases the flattened grip portions 52 so that the cross-section of thetube passage 54 returns to its elongated configuration. Alternatively,the cross-section of the tube passage 54 may include other features tohelp grip the catheter tube 21, such as teeth or other projections.

[0024]FIG. 3 shows an alternate embodiment in the form of an insertioncontrol assembly 60. The insertion control assembly 60 includes athreaded sleeve 62 having a thru-hole 64 and external threads 66 on oneend of the sleeve 62. The thru-hole 64 has a tapered surface 68 thataccepts a tapered collet 70, as shown in FIG. 3. The tapered collet 70includes a channel 72 therethrough. A mating nut 74 includes a thru-hole76 and internal threads 78 that are adapted to engage the externalthreads 66 of the threaded sleeve 62. The catheter tube 21 passesthrough the thru-hole 64 of the threaded sleeve 62, the channel 72 ofthe tapered collet 70, and the thru-hole 76 of the mating nut 74. Whenthe threaded sleeve 62 and the mating nut 74 are engaged and tightened,the threaded sleeve 62 deflects and compresses the tapered collet 70around the catheter tube 21, thereby securing the insertion controlassembly 60 to the catheter tube 21.

[0025]FIG. 4 is a cross-sectional view of the distal spreader connector28 shown in FIG. 1. As the catheter tube 21 is advanced through thedistal spreader connector 28 and the adapter device 38, the externalsleeve 46 begins to bunch up near the distal spreader connector 28. Thecone-shaped extension 36 of the distal spreader connector 28 acts tospread or deflect the sleeve 46 as the catheter tube 21 is advanced andprevent the sleeve 46 from interfering with the tube opening or aperture37 of the extension 36 of the distal spreader connector 28. The sleeve46 is attached to the distal spreader connector 28 between the collar 35and the extension 36, as shown in FIG. 4.

[0026]FIGS. 5A and 5B show an alternate embodiment in the form of adistal spreader connector 80. In this embodiment, the distal spreaderconnector 80 includes a set of four tapered ribs 82 that extend from anextension 84. The tapered ribs 82 provide further deflection andspreading of the sleeve 46 as the catheter tube 21 is advanced.Accordingly, the distal spreader connector 80 deflects the sleeveadjacent to the tube opening of the distal spreader connector.

[0027] While the specific embodiments have been illustrated anddescribed, numerous modifications come to mind without significantlydeparting from the spirit of the invention and the scope of protectionis only limited by the scope of the accompanying claims.

What is claimed is:
 1. A catheter comprising: a tube having a first endand a second end, the first end receivable by a first connector coupledto a medical device and the second end receivable by a second connectorin fluid communication with an anatomical passageway of a patient, thesecond end being movable in a direction of insertion toward the patientso that a variable portion of the tube is disposed between the firstconnector and the second connector; and an insertion controlleradjustably positioned on the variable portion of the tube, the insertioncontroller having a tube engagement member and a biasing member, thebiasing member operable to cause the tube engagement member to bemovable between: (a) a predisposed first position engaged with the tube;and (b) a second position disengaged from the tube.
 2. The catheter ofclaim 1, wherein the tube has a diameter.
 3. The catheter of claim 2,wherein the biasing member of the insertion controller includes aflexible wall having an outer surface and an inner surface, the innersurface defining a tube passageway having a plurality of variablediameters.
 4. The catheter of claim 3, wherein the flexible wall isflexible between: (a) a predisposed position wherein at least one of thevariable diameters is less than the diameter of the tube; and (b)another position wherein each of the variable diameters is greater thanthe diameter of the tube.
 5. The catheter of claim 4, wherein the outersurface of the flexible wall has a plurality of grip portions whichassist a user in pinching the insertion controller in order toreposition the insertion controller on the tube.
 6. The catheter ofclaim 1, wherein the insertion controller has a tactile indicator whichprovides a signal to a user that the tube has been moved a certaindistance.
 7. The catheter of claim 1, wherein the second connector isadapted to be operatively coupled to an endotracheal tube receivable bythe patient.
 8. The catheter of claim 1, wherein the medical deviceincludes negative pressure produced by a suction apparatus.
 9. Thecatheter of claim 1, wherein the second connector is in fluidcommunication with a ventilation circuit.
 10. The catheter of claim 9,wherein the ventilation circuit includes positive pressure produced by aventilation device.
 11. A catheter comprising: a tube having a first endand a second end, the first end receivable by a first connector coupledto a medical device and the second end receivable by a second connectorin fluid communication with an anatomical passageway of a patient, thesecond end being movable in a direction of insertion toward the patientso that a variable portion of the tube is disposed between the firstconnector and the second connector; indicia located on at least part ofthe variable portion of the tube; and an insertion controller adjustablypositioned on the variable portion of the tube, the insertion controllerhaving a tube engagement member and a biasing member, the biasing memberoperable to cause the tube engagement member to have: (a) a predisposedfirst position engaged with the tube; and (b) a second positiondisengaged from the tube.
 12. The catheter of claim 11, wherein the tubehas a diameter.
 13. The catheter of claim 12, wherein the biasing memberof the insertion controller includes a flexible wall having an outersurface and an inner surface, the inner surface defining a tubepassageway having a plurality of variable diameters.
 14. The catheter ofclaim 13, wherein the flexible wall is flexible between: (a) apredisposed position wherein at least one of the variable diameters isless than the diameter of the tube; and (b) another position whereineach of the variable diameters is greater than the diameter of the tube.15. The catheter of claim 14, wherein the outer surface of the flexiblewall has a plurality of grip portions which assist a user in pinchingthe insertion controller in order to reposition the insertion controlleron the tube.
 16. The catheter of claim 11, wherein the insertioncontroller has a tactile indicator which provides a signal to a userthat the tube has been moved a certain distance.
 17. The catheter ofclaim 11, wherein the second connector is adapted to be operativelycoupled to an endotracheal tube receivable by the patient.
 18. Thecatheter of claim 11, wherein the medical device includes negativepressure produced by a suction apparatus.
 19. The catheter of claim 11,wherein the second connector is in fluid communication with aventilation circuit.
 20. The catheter of claim 19, wherein theventilation circuit includes positive pressure produced by a ventilationdevice.
 21. A catheter comprising: a tube having a diameter, a first endand a second end, the first end receivable by a first connector coupledto a medical device and the second end receivable by a second connectorin fluid communication with an anatomical passageway of a patient, thesecond end being movable in a direction of insertion toward the patientso that a variable portion of the tube is disposed between the firstconnector and the second connector; indicia located on at least part ofthe variable portion of the tube; and an insertion controller adjustablypositioned on the variable portion of the tube, the insertion controllerincluding a flexible wall having an outer surface and an inner surface,the inner surface defining a tube passageway having a plurality ofvariable diameters, the flexible wall being flexible between: (a) apredisposed position wherein at least one of the variable diameters isless than the diameter of the tube; and (b) another position whereineach of the variable diameters is greater than the diameter of the tube,the insertion controller further including a plurality of substantiallyflattened grip portions positioned at opposite sides of the flexiblewall.
 22. The catheter of claim 21, wherein the insertion controller hasa tactile indicator which provides a signal to a user that the tube hasbeen moved a certain distance.
 23. The catheter of claim 21, wherein thesecond connector is adapted to be operatively coupled to an endotrachealtube receivable by the patient.
 24. The catheter of claim 21, whereinthe medical device includes negative pressure produced by a suctionapparatus.
 25. The catheter of claim 21, wherein the second connector isin fluid communication with a ventilation circuit.
 26. The catheter ofclaim 21, wherein the ventilation circuit includes positive pressureproduced by a ventilation device.